ALLERNIL-HS _{Eye Drops
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(Olopatadine Ophthalmic Solution IP)

DESCRIPTION:

ALLERNIL-HS Eye Drops (Olopatadine Ophthalmic Solution IP) is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor ofhistamine release from the mast cell,for topical administration to the eyes.
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COMPOSITION:

Each ML Contains :

• Olopatadine Hydrochloride
• eq. to Olopatadine U.S.P.                            0.2mg
• Benzalkonium Chloride Solution I.P.          0.1mg
  (As preservative)
• Sterile Aqueous Vehicle.                              q. s..
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CLINICAL  PHARMACOLOGY

Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamineH1-antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells. Olopatadine is devoid of effects on alpha-adrenergic, dopamine and muscarinic type 1 and 2 receptors. Following topical ocular administration in man, olopatadine was shown to have low systemic exposure. Two studies in normal volunteers(totaling 24 subjects) dosed bilaterally with olopatadine 0.15% ophthalmic solution once every 12 hours for 2 weeks demonstrated plasma concentrations to be generally below the quantitation limit of the assay (<0.5ng/mL). Samples in which olopatadine was quantifiable were typically found within 2 hours of dosing and ranged from 0.5 to 1.3 ng/mL. The half-life in plasma was approximately 3 hours, and elimination was predominantly through renal excretion. Approximately 60-70% of the dose was recovered in the urine as parent drug. Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentrations in the urine.

Results from an environmental study demonstrated that ALLERNIL-HS Eye Drops (Olopatadine Ophthalmic Solution IP) was effective in the treatment of the signs and symptoms of allergic conjunctivitis when dosed twice daily for up to 6 weeks. Results from conjunctival antigen challenge studies demonstrated that ALLERNIL-HS Eye Drops (Olopatadine Ophthalmic Solution IP), when subjects were challenged with antigen both initially and up to 8hours after dosing, was significantly more effective than its vehicle in preventing ocular itching associated with allergic conjunctivitis.

INDICATIONS AND USAGE

ALLERNIL-HS (Olopatadine Ophthalmic Solution IP) Eye Drops is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.

DOSAGE AND ADMINISTRATION

The recommended dose is one drop in each affected eye twice daily at an interval of 6 to 8 hours.

CONTRAINDICATIONS

ALLERNIL-HS Eye Drops(Olopatadine Ophthalmic Solution IP) is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any component of this product.

ALLERNIL-HS Eye Drops (Olopatadine Ophthalmic Solution IP) is for topical use only and not for injection or oral use.

PRECAUTIONS

Patients should be given the following instructions to prevent contamination the dropper tip and solution, care should betaken not to touch the eyelids or surrounding areas with the dropper tip. The bottle should be kept tightly closed when not in use. if the eye is red, contact lens should not be worn.

ALLERNIL-HS (Olopatadine Ophthalmic Solution IP) Eye Drops should not be used to treat contact lens related irritation. Solution IP) Benzalkonium Chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least ten minutes after instilling ALLERNIL-HS Eye Drops (Olopatadine Ophthalmic Solution IP) before they insert their contact lenses.

Pregnancy

Olopatadine was found not to be teratogenic in rats and rabbits. There are ,however, no adequate and well-controlled studies in pregnant woman. Because animal studies are not always predictive of human responses, this drug should be used in pregnant woman only if the potential benefit o the mother justifies the potential risk to the embryo or fetus. Nursing Mothers.

Olopatadine has been identified in the milk of following oral administration. it is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when ALLERNIL-HS Eye Drops(Olopatadine Ophthalmic Solution IP) is administered to a nursing mother.

Pediatric Use

safety and effectiveness of ALLERNIL-HS Eye Drops (Olopatadine Ophthalmic Solution IP)pediatric patients below the age of 3 years have not been established .

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTION

ALLERNIL - HS Eye Drops ( Olopatadine Ophthalmic Solution IP) is well tolerated Side effects reported by a minority of patients are headache, Blurred vision, burning or stinging, dry eye, foreign body sensation hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritis, rhinitis, sinusitis, and taste perversion. Some of these events were similar to the underlying disease being studied.

STORAGE

Keep in a cool &dark place.Below 250C. Do not allow to Freeze.

SHELF LIFE

24 Months

HOW SUPPLIED

ALLERNIL - HS Eye Drops ( Olopatadine Ophthalmic Solution IP) is supplied in 5 mL poly bottles.
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